Safety Study of Meningococcal ACYW135 Polysaccharide Conjugate Vaccine in Healthy Volunteers Aged Above 3 Months

Beijing Zhifei Lvzhu Biopharmaceutical

Status and phase

Unknown

Phase 1

Conditions

Meningitis, Meningococcal

Treatments

Biological: Meningococcal ACYW135 Polysaccharide Conjugate Vaccine

Study type

Interventional

Funder types

Other

Industry

Identifiers

201518603

Details and patient eligibility

About

The purpose of this study is to evaluate safety of meningococcal ACYW135 polysaccharide conjugate vaccine in healthy volunteers aged above 3 Months

Enrollment

200 estimated patients

Sex

All

Ages

3+ months old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

3-11 months health infants who haven't immuned with Meningococcal A and C Conjugate Vaccine and population above 1 year old who have't given boost immunity.
Subject or legal representative who consent and has signed written informed consent.
Subject who did't immune with any live vaccine within 14 days and inactivated vaccine within 7 days before vaccination.
Subject and parent/guardian who is able to comply with all study procedures.
Axillary temperature ≤37.0 ℃.

Exclusion criteria

History of allergy，eclampsia, epilepsy, encephalopathy and mental disease or family disease.
Allergic history after vaccination.
History of meningitis infection disease.
Acute Febrile illness and Infectious Diseases.
Febrile illness (temperature ≥ 38°C) in the 3 days.
Immunodeficiency diseases patients who administered with immunosuppressive agents.
Children within 1 year old with abnormal labor, asphyxia rescue history,congenital malformations,genetic defects, eccyliosis or severe chronic disease.
Liver and kidney or cardiopulmonary disease，acute hypertension and diabetes.
In pregnancy or lactation or pregnant women.
Subject who plan to participate in or is in any other drug clinical trial.
Meningococcal vaccine contraindication.
Any condition that, in the judgment of investigator, may affect trial assessment.